NCT05615363CompletedPhase 2
A Dose-ranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF])
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Doseranging Trial of OPC-131461 in Cardiac Edema (Congestive Heart Failure [CHF])
Source: ClinicalTrials.gov · Last updated 20 Oct 2025
Brief summary (registry, in English)
To investigate the dose response in respect of weight decrease following repeated oral administration of OPC-131461 at 1, 2, 5, and 10 mg or placebo in patients with CHF with volume overload despite having received diuretics other than vasopressin antagonists
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 157 (actual)
- First submitted
- 7 Nov 2022
- Start date
- 10 Jan 2023
- Primary completion date
- 21 Oct 2024
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Diseases
- Heart failure
- NCT number
- NCT05615363
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 157
- From 10 Jan 2023 to the primary completion date, 21 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subjects with acute heart failure
Other
- Subjects with an assisted circulation device
- Subjects who cannot sense thirst or who have difficulty in ingesting water
Who the study is looking for
- Subjects with CHF with lower limb edema, pulmonary congestion, or jugular venous distension due to volume overload.
- Subjects undergoing any of the following diuretic therapies
- Loop diuretics at a dosage equivalent to 40 mg/day or more of furosemide tablet/fine granule
- Concomitant administration of a loop diuretic and a thiazide diuretic (including similar drugs) at any doses
- Concomitant administration of a loop diuretic and a mineralocorticoid receptor antagonist or potassium-sparing diuretic at any doses
- Subjects who were currently hospitalized or who are able to be hospitalized
Age in the registry: 18 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Harasanshin Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.